CLEVELAND, Ohio (WOIO) - Roughly one in five Americans, suffer from the pain and discomfort of heartburn.
But a popular medication, Zantac, that’s been around for decades and has offered relief, has been voluntarily recalled over concerns about the level of NDMA, a probable human carcinogen.
So, what are patients to do now? And is it too late for those who’ve been on these medications long term?
Millions of Americans who suffer from heartburn use whatever they can to ease their discomfort.
“I was continuously on Zantac. I had it in my duty bag, trunk of my zone car, locker at work,” said Michael Konn.
For nearly 19 years, Konn used Zantac to treat his acid reflux.
He was an otherwise healthy guy, who worked as a patrolman with the Cleveland Police Department for 15 years, when he was diagnosed with bladder cancer.
“I went to the bathroom and started urinating blood. I was scared,” he said.
His doctor asked him about common risk factors like a family history of bladder cancer, smoking or factory work.
But none applied to then 37 year old Konn.
“He was surprised, he said you’re very young. You usually get this in you 70s,” he recalled his doctor saying.
His cancer forced him to retire at 40 from a job he loved, and go back to college so he could earn a living.
Something Konn heard on television lead him to look into a connection between his heartburn medication and his cancer.
He started researching, looking for an explanation.
“Was is something I did? I don’t believe it was. I believe it was from taking Zantac for all those years,” Konn said.
After learning about the Zantac voluntary recall and it’s generic form, Ranitidine, he hired local firm, Kelley and Ferraro.
Konn is now one of a growing number of people linking their cancers to their heartburn medication through lawsuits.
I reached out to Zantac’s maker, Sanofi, about the recall.
“The longstanding science supports the safety of Zantac®, which has been available over-the-counter for more than two decades. Sanofi is working closely with the FDA and other regulatory bodies to evaluate any potential safety risks associated with ranitidine products and Zantac OTC products remain off the market in light of those continuing investigations. Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.”
Kelley and Ferraro Managing Partner John Murphy believes the scope of the developing lawsuits will be huge.
The local firm is getting 3-4 new cases every day.
“It will be, I believe, the largest mass tort of our time,” Murphy said.
Kelley and Ferraro has filed the only 9 cases in the state of Ohio.
So where does all this leave Genine Apidone, from Shaker Heights?
“My esophagus was in pretty bad shape,” Apidone said.
She and her doctor had planned to put her on Zantac, and get her off of Prilosec because of its long term side effects.
“Ok, well that’s plan’s off the table now, since that’s not an option,” Apidone said.
Dr. Danny Raad, with University Hospitals said the voluntary recall is no reason to panic.
“In fact you can find that amount of NDMA on some of your frozen and processed meats even,” he said.
He has, however, taken all of his patients off Zantac as a precaution, and says there are plenty of effective, safe alternatives for patients who were on a Ranitidine.
Countless people have been self-medicating with over the counter Zantac, but Dr. Raad still says the recall is precautionary not reactionary.
“A lot of patients have been taking this medication chronically and we don’t have any clincial evidence that patients who took this medication have a higher chance of having a certain type of cancer,” Dr. Raad said.
"The unfortunate part is the damage may have already been done," Murphy said.
He is now awaiting a study commissioned by Sloan Kettering Cancer Center in New York, which he is researching whether Zantac and its generic Ranitidine increase the risk of certain kinds of cancer.
He believes the FDA should have been a better watch dog, and although the FDA is ongoing, he thinks the pharmaceutical companies should take responsibility in court, through a multi-billion dollar settlement.
Konn and Apidone are now using diet alone to control their heartburn.
Moving forward, Konnn would like to see the drug makers held accountable.
“Look at the side of a pack of cigarettes and say ‘hey, this causes cancer.’ Grab a pack a pack of Zantac, and it doesn’t say that anywhere otherwise I would have never taken it,” Konn said.
The FDA has tested samples of over-the-counter alternatives, like Tagamet, Pepcid, Nexium, Prilosec and Prevacid and found no traces of NDMA.
We checked whether Sanofi had tried to settle litigation concerning Zantac, but no documents were found.